Tacrolimus, Sirolimus and Methotrexate as Graft Versus Host Disease Prophylaxis After Blood Stem Cell Transplantation

This study has been completed.

Sponsor:

Collaborators:

Brigham and Women's Hospital

Beth Israel Deaconess Medical Center

Massachusetts General Hospital

Information provided by (Responsible Party):

Edwin P. Alyea, MD, Dana-Farber Cancer Institute

ClinicalTrials.gov Identifier:

NCT00146614

First received: September 6, 2005

Last updated: March 6, 2012

Last verified: March 2012

History of Changes

Purpose

The purpose of this study is to determine if the incidence of Graft vs. Host Disease (GVHD) after non-myeloablative transplantation can be reduced by using a combination of three immune suppressive medication; sirolimus, tacrolimus and methotrexate.

Condition	Intervention	Phase
Graft Versus Host Disease Hematologic Malignancies	Drug: Sirolimus Drug: Tacrolimus Drug: Methotrexate Procedure: Stem Cell Transplantation	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Tacrolimus, Sirolimus and Methotrexate as Graft Versus Host Disease Prophylaxis After Allogeneic Non-Myeloablative Peripheral Blood Stem Cell Transplantation

Resource links provided by NLM:

Drug Information available for: Methotrexate Methotrexate sodium Sirolimus Tacrolimus

Genetic and Rare Diseases Information Center resources: Homologous Wasting Disease

U.S. FDA Resources

Further study details as provided by Edwin P. Alyea, MD, Dana-Farber Cancer Institute:

Primary Outcome Measures:

To assess the effect on the incidence and severity of GVHD by adding sirolimus, tacrolimus and methotrexate to GVHD prophylaxis.


Estimated Enrollment:	105
Study Start Date:	July 2002
Study Completion Date:	April 2003
Primary Completion Date:	April 2003 (Final data collection date for primary outcome measure)

Detailed Description:

Patients will be admitted to the hospital and receive chemotherapy and stem cell transplant(SCT). The total duration of hospitalization for the procedure is approximately 8 days. Once admitted the patient will receive fludarabine daily for 4 days, busulfex once daily for 4 days. Two days after chemotherapy has ended, the patient will receive the infusion of donor cells.
Just prior to the transplant and following the transplant, patients will receive sirolimus (orally), tacrolimus (orally) and low doses of methotrexate (chemotherapy). Methotrexate will be given on days 1,3 and 6 after transplant.
Sirolimus will be tapered beginning week 9 after transplant if there is no evidence of GVHD and will be eliminated on week 26 if clinically feasible.
Tacrolimus will be tapered beginning week 9 after transplant if there is no evidence of GVHD and will be eliminated on week 26 if clinically feasible.
Patients will also receive medication to help prevent possible infection.
After stem cell infusion, patients will be examined and have blood tests weekly for 1 month. At the 1 month visit, a bone marrow biopsy will performed looking for evidence of donor cells in the bone marrow. After the one month evaluation the patient will be examined every 2 weeks and a repeat bone marrow performed 3-4 months after transplant.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with hematologic malignancies who are at a high risk of complications after conventional transplantation.
Donors (both related and unrelated) who are identical at 6 HLA loci.
Age greater than 18
ECOG Performance Status 0-2
Life expectancy of greater than 100 days.

Exclusion Criteria:

Pregnancy
Evidence of HIV infection
Heart failure uncontrolled by medications
Total Bilirubin > 2.0mg/dl due to hepatocellular dysfunction
AST > 90
Serum creatinine > 2.0
Cholesterol > 300 mg/dl

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146614

Locations


United States, Massachusetts
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Beth Israel Deaconess Medical Center

Massachusetts General Hospital

Investigators


Principal Investigator:	Edwin P. Alyea, MD	Dana-Farber Cancer Institute

More Information


Responsible Party:	Edwin P. Alyea, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00146614 History of Changes
Other Study ID Numbers:	02-057
Study First Received:	September 6, 2005
Last Updated:	March 6, 2012

Keywords provided by Edwin P. Alyea, MD, Dana-Farber Cancer Institute:


Graft versus Host Disease GVHD Stem Cell Transplantation Tacrolimus	Sirolimus Methotrexate allogeneic stem cell transplantation

Additional relevant MeSH terms:


Graft vs Host Disease Immune System Diseases Methotrexate Tacrolimus Sirolimus Everolimus Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action	Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors Calcineurin Inhibitors Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antineoplastic Antifungal Agents

ClinicalTrials.gov processed this record on June 23, 2017

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